Allium Sativum Extract as an Irrigant

NCT ID: NCT03795636

Last Updated: 2019-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-30
• Study Completion Date: 2018-08-15

Brief Summary

Garlic extract as herbal compound has potent antibacterial properties and can be used safely as an irrigant for pulpectomy procedure of primary molars root canals with high clinical and radiographic outcomes

Detailed Description

Aim: This study indented to assess the clinical and radiographic assessment of garlic extract as an intracanal irrigant for pulpectomy of primary molars.

Methodology: 91 child with 100 teeth submitted into this study were equally categorized into the test group (group 1) which irrigated with garlic extract and control group (group 2) that received sodium hypochlorite (NaOCl). Then, each group has been subjected to further specification according to the tooth preoperative clinical and radiographic features into has been into 2 subgroups. Clinical and radiographic success rates were checked at 3, 6 and 12 months. Fisher's exact test for binary variable was used for data analysis with p-value ≤ 0.05.

Conditions

Infected Root Canals of Primary Molars

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Garlic extracts root canal irrigation group

Experimental group treated with garlic extract

A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water

Group Type: EXPERIMENTAL

Garlic extract

Intervention Type: OTHER

A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water

Sodium hypochlorite root canal irrigation group

Control group which treated conventionally using .5 ml of 5.25% NaOCl (COLTENE®ENDO, Switzerland)

Group Type: ACTIVE_COMPARATOR

NaOCl (COLTENE®)

Intervention Type: OTHER

Sodium hypochlorite

Interventions

Garlic extract

A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water

Intervention Type: OTHER

NaOCl (COLTENE®)

Sodium hypochlorite

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Class I or II according to American Society of Anesthesiologists (ASA)

2. Irreversible pulpititis recognised through; (1) profuse bleeding from root canal orifices after complete debridement of coronal pulp tissue and cannot be dominated by moist cotton pellet. (2) History of lingered thermal pain spontaneous nocturnal pain

3. Necrotic pulp tissues which may be asymptomatic or manifested with dull ache pain

4. Pathological tooth mobility

5. Percussion sensitivity

6. Swelling close to involved tooth accompanied with or without fistula Radiographic characteristics of the root and supporting structures

1. Normal radiographic findings

2. Interruption of lamina dura

3. Furcation radiolucency

Exclusion Criteria

• Specifications of exclusion

1. Uncooperativeness of child and/or parents or caregivers behavior

2. Unrestorable tooth

3. Presence of internal root resorption

4. Presence of calcific metamorphosis inside root canals

5. Presence of root resorption exceeding one third of its length

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Elheeny

Lecturer of pediatric dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Elheeny AAH. Allium sativum extract as an irrigant in pulpectomy of primary molars: A 12-month short-term evaluation. Clin Exp Dent Res. 2019 Jun 26;5(4):420-426. doi: 10.1002/cre2.197. eCollection 2019 Aug.

Reference Type: DERIVED

PMID: 31452953 (View on PubMed)

Other Identifiers

307

Identifier Type: -

Identifier Source: org_study_id